Ebola Zaire vaccine (Rx)

Brand and Other Names:Ervebo
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injection, suspension

  • 1mL (single-dose vial)

Immunization Against Ebola Zaire Virus

Indicated for prevention of disease caused by Zaire ebolavirus

1 mL IM once

ACIP recommendations

  • Centers for Disease Control and Prevention's (CDC's) Advisory Committee on Immunization Practices (ACIP) recommends preexposure vaccination for the following people who:
  1. Are responding to an outbreak of Ebola virus disease; or
  2. Work as healthcare personnel at federally-designated Ebola Treatment Centers (ETCs) in the U.S.; or
  3. Work as laboratorians or other staff at biosafety-level 4 facilities in the U.S.

Dosing Considerations

Limitations of use

  • Duration of protection conferred by vaccine is unknown
  • Does not protect against other species of Ebolavirus or Marburgvirus
  • Effectiveness of vaccine when administered concurrently with antiviral medication, immune globulin (IG), and/or blood or plasma transfusions is unknown

<18 years: Safety and efficacy not established

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Interactions

Interaction Checker

and Ebola Zaire vaccine

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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             activity indicator 

            Contraindicated (0)

              Serious - Use Alternative (13)

              • abrocitinib

                abrocitinib decreases effects of Ebola Zaire vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Administration of live vaccines is not recommended during abrocitinib treatment and immediately before or after treatment.

              • anifrolumab

                anifrolumab decreases effects of Ebola Zaire vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Before initiation, update immunization according to current guidelines.

              • atoltivimab/maftivimab/odesivimab

                atoltivimab/maftivimab/odesivimab decreases effects of Ebola Zaire vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Ebola monoclonal antibodies may interfere with immune response of live vaccines. Refer to vaccine guidelines for vaccination timing during and following treatment. .

              • axicabtagene ciloleucel

                axicabtagene ciloleucel decreases effects of Ebola Zaire vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live virus vaccines is not recommended for at least 6 weeks before starting lymphodepleting chemotherapy, during CAR-T cell treatment, and until immune recovery following treatment. .

              • ciltacabtagene autoleucel

                ciltacabtagene autoleucel decreases effects of Ebola Zaire vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live virus vaccines is not recommended for at least 6 weeks before starting lymphodepleting chemotherapy, during CAR-T cell treatment, and until immune recovery following treatment. .

              • cyclosporine

                cyclosporine decreases effects of Ebola Zaire vaccine by pharmacodynamic antagonism. Contraindicated. Avoid live vaccines in immunocompromised patients due to the risk of developing a clinical infection from the live vaccine. Inadequate immune response to the vaccine may also occur in the presence of immunosuppressants. Avoid live vaccines for at least 3 months after cessation of immunosuppressant therapy unless the benefit of vaccine administration outweighs the potential risk.

              • idecabtagene vicleucel

                idecabtagene vicleucel decreases effects of Ebola Zaire vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live virus vaccines is not recommended for at least 6 weeks before starting lymphodepleting chemotherapy, during CAR-T cell treatment, and until immune recovery following treatment. .

              • ofatumumab SC

                ofatumumab SC decreases effects of Ebola Zaire vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Administer all immunizations according to immunization guidelines at least 4 weeks prior to initiation of ofatumumab SC for live or live-attenuated vaccines, and whenever possible.

              • ozanimod

                ozanimod decreases effects of Ebola Zaire vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live-attenuated vaccines with ozanimod during treatment and for up to 3 months after discontinuing ozanimod. .

              • ponesimod

                ponesimod decreases effects of Ebola Zaire vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live attenuated vaccines at least 1 month before initiating, during, and for 1-2 weeks after treatment. Coadministration with live attenuated vaccines may increase infection risk.

              • satralizumab

                satralizumab decreases effects of Ebola Zaire vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. ive vaccines are not recommended during treatment. Administer all immunizations according to immunization guidelines. At least 4 weeks before initiating for live or live-attenuated vaccines.

              • tisagenlecleucel

                tisagenlecleucel decreases effects of Ebola Zaire vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live virus vaccines is not recommended for at least 6 weeks before starting lymphodepleting chemotherapy, during CAR-T cell treatment, and until immune recovery following treatment. .

              • voclosporin

                voclosporin decreases effects of Ebola Zaire vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Immunosuppressants also increase risk of infection with concomitant live vaccines. Avoid live vaccines for at least 3 months after immunosuppressants.

              Monitor Closely (1)

              • betibeglogene autotemcel

                betibeglogene autotemcel, Ebola Zaire vaccine. Other (see comment). Use Caution/Monitor. Comment: Follow institutional guidelines for vaccine administration. Safety of live vaccines during or following treatment not studied. .

              Minor (0)

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                Adverse Effects

                >10%

                Injection site pain (34-69.5%)

                Headache (36.9%)

                Feverishness (34.3%)

                Muscle pain (32.5%)

                Fatigue (18.5%)

                Joint pain (17.9%)

                Injection site swelling (16.5%)

                Injection site redness (11.9%)

                1-10%

                Nausea (8%)

                Joint pain/tenderness (7%)

                Arthritis (0.8-4.7%)

                Rash (3.6-3.8%)

                Abnormal sweating (3.2%)

                Local reactions (eg, redness, swelling) (1.8%)

                Vesicular lesions (1.5%)

                <1%

                Arthropathy (joint redness/warmth) (0.6%)

                Joint swelling (0.4%)

                Joint stiffness (0.4%)

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                Warnings

                Contraindications

                Hypersensitivity to any component of the vaccine, including rice protein

                Cautions

                There were 2 reports of anaphylaxis; monitor for signs and symptoms of hypersensitivity reactions following vaccination; appropriate medical treatment and supervision must be available in case of an anaphylactic event following administration

                Vaccination may not protect all individuals; vaccinated individuals should continue to adhere to infection control practices to prevent Zaire ebolavirus infection and transmission

                Safety and effectiveness have not been assessed in immunocompromised individuals; weigh the risk of vaccination in immunocompromised individuals against the risk of disease due to Zaire ebolavirus

                Vaccine virus RNA has been detected by RT-PCR in blood, saliva, urine, and fluid from skin vesicles of vaccinated adults; transmission of vaccine virus is a theoretical possibility

                Drug interaction overview

                • Interference with laboratory tests
                  • Following vaccination, individuals may test positive for anti-Ebola glycoprotein (GP) antibody and/or Ebola GP nucleic acid or antigens
                  • GP-based testing may have limited diagnostic value during period of vaccine viremia, in the presence of vaccine-derived Ebola GP, and following antibody response to the vaccine
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                Pregnancy & Lactation

                Pregnancy

                There are no adequate and well-controlled studies in pregnant women, and human data available from clinical trials are insufficient to establish the presence or absence of vaccine-associated risk during pregnancy

                Consider the woman’s risk of exposure to Zaire ebolavirus before vaccination

                Clinical considerations

                • Fetal and neonatal outcomes are universally poor among pregnant women infected with Zaire ebolavirus
                • Majority of such pregnancies end in miscarriage or stillbirth
                • In pregnancies where live birth does occur, neonates generally do not survive
                • Potential for transmission of the vaccine virus from mother to the fetus/neonate is unknown

                Lactation

                Human data are not available to assess the effects on milk production, its presence in breast milk, or its effects on the breastfed child

                Consider developmental and health benefits of breastfeeding along with the mother’s clinical need and any potential adverse effects on the breastfed child or from the underlying maternal condition

                For preventive vaccines, the underlying condition is susceptibility to disease prevented by the vaccine

                Pregnancy Categories

                A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

                B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

                C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

                D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

                X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

                NA: Information not available.

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                Pharmacology

                Mechanism of Action

                Recombinant vesicular stomatitis virus-Zaire ebolavirus (rVSV-ZEBOV; V920) is a replication-competent vaccine

                Genetically engineered to express a glycoprotein from the Zaire ebolavirus to provoke a neutralizing immune response to the Ebola virus

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                Administration

                IM Preparation

                Thaw vial at room temperature until no visible ice is present; do not thaw vial in a refrigerator

                Gently invert vial several times

                Visually inspect for particulate matter and discoloration before use, vaccine is a colorless to slightly brownish-yellow liquid with no particulates visible

                Use the vaccine immediately after thawing

                Withdraw 1-mL dose from vial using a sterile needle and sterile syringe

                IM Administration

                Administer a 1-mL dose IM, preferably in the deltoid area of the nondominant arm

                Discard unused portion

                Storage

                Unopened vials: Freeze at -80 to -60ºC (-112 to -76ºF) in the original carton to protect from light; do not thaw the vial in a refrigerator

                Thawed vials: If not used immediately, refrigerate at 2-8ºC (35.6-46.4ºF) for a total time of no more than 2 weeks and at room temperature (up to 25ºC; 77ºF) for a total time of no more than 4 hr

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                Patient Handout

                A Patient Handout is not currently available for this monograph.
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                Formulary

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                Tier Description
                1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
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                NC NOT COVERED – Drugs that are not covered by the plan.
                Code Definition
                PA Prior Authorization
                Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                QL Quantity Limits
                Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
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                Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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                Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.